Spots Global Cancer Trial Database for Thalidomide in Treating Patients With Gynecologic Sarcomas
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Trial Identification
Brief Title: Thalidomide in Treating Patients With Gynecologic Sarcomas
Official Title: Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
Study ID: NCT00006005
Interventions
Study Description
Brief Summary: RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
Detailed Description: OBJECTIVES: * Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin. * Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population. * Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients. OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cancer Center of Albany Medical Center, Albany, New York, United States
Albert Einstein Clinical Cancer Center, Bronx, New York, United States
North Shore University Hospital, Manhasset, New York, United States
St. Vincent's Comprehensive Cancer Center, New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division, New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
New York Medical College, Valhalla, New York, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Scott Wadler, MD
Affiliation: Weill Medical College of Cornell University
Role: STUDY_CHAIR
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